510(k) · Cleared
ClearedModification to Aurora Mri System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aurora Imaging Technology, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 16, 2008 as substantially equivalent to K032082 (Aurora Imaging Technology, Inc., 2003) and 2 other predicates after a 288-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Sep 16, 2008
- Review
- 288 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K012154 (2001). 4 ancestors in all, the oldest K930265 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012154 | Aurora Magnetic Resonance Diagnostic Device | Aurora Imaging Technology, Inc. | 2001 | — |
| −1 | K032082 | Aurora | Aurora Imaging Technology, Inc. | 2003 | — |
| 0 (this device) | K073425 | Modification to Aurora Mri System | Aurora Imaging Technology, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032082 | AuroraSummary page 2…Common/Usual Name: Magnetic Resonance Imaging Device Classification Name: Magnetic Resonance Diagnostic Device 3. Predicate Device(s) Aurora MRI System (K032082) GE Probe (K930265) Siemens (K951650) 4. Device Description The modified AURORA is identical to the AURORA bre… | 2003 |
| * | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HTSummary page 2…tic Resonance Imaging Device Classification Name: Magnetic Resonance Diagnostic Device 3. Predicate Device(s) Aurora MRI System (K032082) GE Probe (K930265) Siemens (K951650) 4. Device Description The modified AURORA is identical to the AURORA breast imaging system… | 1995 |
| * | K951650 | Clinical Proton Spectroscopy OptionSummary page 2…evice Classification Name: Magnetic Resonance Diagnostic Device 3. Predicate Device(s) Aurora MRI System (K032082) GE Probe (K930265) Siemens (K951650) 4. Device Description The modified AURORA is identical to the AURORA breast imaging system cleared by the FDA thro… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K032082.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, and sagittal cross-sectional images that display the internal structure of breast tissue, axilla, and chest wall local to the breast. The images produced by the MR system reflect the spatial distribution of protons…
Read the full statement (237 words)
The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, and sagittal cross-sectional images that display the internal structure of breast tissue, axilla, and chest wall local to the breast. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The AURORA is a dedicated breast MRI system intended for breast imaging.
Anatomical region: Breast tissue, axilla, and chest wall local to the breast
Nucleus excited: Proton
Diagnostic uses: 2D, 3D T1-/T2-weighted imaging
T1, T2, proton density measurements
Image processing
Imaging Capabilities: 2D Spin Echo (SE)
2D/3D Gradient Echo (GRE)
Fat Suppression
Imaging Processing: Image Subtraction
Image Filtering
The Aurora MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073425 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073425: Modification to Aurora Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073425
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026